The U.S. Food and Drug Administration (FDA) may not renew the Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine for children under the age of five, the company said. The possible ...

CLEVELAND, Ohio – Moderna requested emergency use authorization of its COVID-19 vaccine for children under 6, and half of all Americans have been infected with COVID-19. Cleveland.com is rounding up ...

Moderna asked the Food and Drug Administration (FDA) on Thursday to authorize a fourth shot of its COVID-19 vaccine. The biotech company wrote in a release that it had requested the agency amend the ...

Younger children could soon be eligible to receive an updated COVID-19 booster shot. Pfizer and BioNTech on Monday said they completed their submission to the U.S. Food and Drug Administration for ...

Moderna is seeking emergency use authorization from the US Food and Drug Administration for its Covid-19 vaccine for children 6 months through 5 years of age, the company said Thursday. “We believe ...

Transitioning COVID-19 tests from emergency use authorization to the traditional pre-market pathway has long been a goal for the FDA. “Today’s authorization is the first at-home COVID-19 test granted ...

The Food and Drug Administration (FDA) said on Wednesday that the COVID-19 monoclonal antibody treatment bebtelovimab from Eli Lilly is no longer authorized for emergency use in the U.S. as it is not ...

Pfizer and BioNTech asked U.S. regulators on Tuesday to authorize an additional booster dose of their COVID-19 vaccine for seniors. The companies said Israeli data suggests that people over the age of ...

The U.S. Food and Drug Administration (FDA) has just extended the emergency use authorization (EUA) for Novavax’s adjuvanted (NVX-CoV2373) Covid-19 vaccine to now include a first booster dose for ...